Assessing the Impact of High Theacrine Doses on Hemodynamic Measures

NCT07376564 | Completed

• 1 other identifier: 2791
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This project measured physiological and cognitive variables to determine the effectiveness of Theacrine (TCR) as a stimulant at doses greater than those previously tested. The study will be the first TCR study to use doses relative to body weight and will investigate impacts on regular caffeine consumers. A secondary aim of the study is to determine the impact of acute TCR supplementation on salivary cortisol and sAA, two physiological measures of stress and sympathetic nervous system activation. The findings of the study will provide new insight into the effects of higher TCR dosages, contributing to the analysis of TCR as a caffeine alternative for individuals with hypertension, tachycardia, or healthy caffeine consumers wanting to avoid a stimulant with adverse or habitual effects

Conditions

Hemodynamic Measure; Cognitive Performance in Healthy Volunteers

Keywords

Theacrine; Hemodynamic measures; Cognitive Performance; Cortisol

Outcome Measures

Primary Outcomes (5)

• Change in systolic blood and diastolic blood pressure post consumption of theacrine

  mmHg change in blood pressure measures

  Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

• Change in heart rate post consumption of theacrine

  beats per minute change in heart rate measure

  Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

• Changes in executive function as a measure of cognitive performance using the Trail Making Test

  Time to completion of the Trail Making Test as a measure of executive function

  Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

• Changes in attention as a measure of cognitive performance using the Flanker Inhibitory Control and Attention task

  Accuracy of congruent and incongruent trials as measures of attention

  Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

• Changes in focus as a measure of cognitive performance using the Flanker Inhibitory Control and Attention task

  Reaction time were recorded as measures of focus

  Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

Secondary Outcomes (1)

• Change in salivary cortisol and alpha-amylase post consumption of theacrine

  Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

Study Arms (4)

Placebo

PLACEBO COMPARATOR

6 mg/kg Maltodextrin Placebo

Dietary Supplement: Maltodextrin (Placebo)

Low dose

EXPERIMENTAL

3mg/kg Theacrine

Dietary Supplement: Low dose theacrine

Medium dose

EXPERIMENTAL

6mg/kg Theacrine

Dietary Supplement: Medium dose theacrine

High dose

EXPERIMENTAL

9mg/kg Theacrine

Dietary Supplement: High dose theacrine

Interventions

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

6 mg/kg Maltodextrin Placebo

Placebo

Medium dose theacrine DIETARY_SUPPLEMENT

6mg/kg theacrine

Medium dose

High dose theacrine DIETARY_SUPPLEMENT

9mg/kg theacrine

High dose

Low dose theacrine DIETARY_SUPPLEMENT

3mg/kg theacrine

Low dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- habitual caffeine consumer (≥2 days/week)

You may not qualify if:

• existing heart disease or conditions (cardiovascular and/or heart disease, stroke, diabetes hypertension, tachycardia)
• a smoker
• allergy to caffeine or Theacrine
• caffeine sensitivity (negative symptoms such as jitters after consuming low doses)
• pregnant
• on heart or blood pressure medication

Sponsors & Collaborators

• Titch Madzima: lead

Study Sites (1)

Department of Exercise Science, Koury Athletics Center at Elon University

Elon, North Carolina, 27244, United States

Location

MeSH Terms

Interventions

maltodextrin; 1,3,7,9-tetramethyluric acid

Study Officials

• Takudzwa A Madzima, PhD

  Elon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 29, 2026
• Study Start: August 9, 2023
• Primary Completion: September 27, 2024
• Study Completion: November 1, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD data sharing will be available starting 6 months after publication
• Access Criteria: The data generated and analyzed during this study will be available starting 6 months after publication upon request from the principal investigator

Locations

US (1)